FDA Approved – Abbot’s FreeStyle Pro Bloodless Glucose Meter

Abbot’s FreeStyle Libre Pro System Receives FDA Approval For Medical Practitioners To Use With Diabetes Patients.

On 28th September 2016, Abbot announced that the FDA (Food and Drug Administration) had approved the FreeStyle Libre Pro System, a bloodless glucose monitor for use by healthcare professionals on diabetes patients.

The system is designed to empower physicians to provide better management of diabetes. The system provides physicians with a clear visual snapshot of blood glucose data, commonly known as AGP (Ambulatory Glucose Profile). Besides giving a more clear and simplified view of the blood glucose levels, healthcare providers can also see and analyze trends and patterns within those glucose levels. This information has proven to be very valuable because it helps doctors make customized treatment plans for diabetes patients and at a lower cost compared to other continuous glucose monitoring products available in the market today.

FreeStyle Libre Pro makes a massive transformation in the way healthcare providers assess diabetes patients especially when it comes to critical decisions around nutrition, medication and insulin. This innovative technology provides a viable solution to the challenges that come with the need for dependable and complete blood glucose data. This data is vital for the doctor to help the patient achieve optimal health.

How does the FreeStyle Libre Pro System Work?

The FreeStyle Libre Pro system is applied to diabetes patients by healthcare practitioners in a hospital or clinic setting. The doctor applies a very small sensor on the back of the diabetes patient’s upper arm. The round water resistant sensor is held firmly in place with an adhesive pad and remains on the patient’s arm for 14 days. During this period, the device does not require any patient interaction or the need for patients to calibrate the sensor or draw blood via a fingerstick.

The sensor measures glucose continuously in interstitial fluid via a very small filament that is usually inserted just under the patient’s skin. This enables the sensor to record glucose in 15 minutes intervals capturing about 1,340 blood glucose results in the 14-day period. The patient returns to the physician after 14 days where the physician will scan the sensor using a FreeStyle Libre Pro reader and download the glucose results stored in the patient’s sensor. The 14 days’ worth of blood glucose results can be scanned and downloaded in as little as 5 seconds.

Advantages of the FreeStyle Libre Pro System compared to other CGM systems

Provides reliable blood glucose data

Doctors receive 14 days’ worth of continuous blood glucose data that is based on uninterrupted day-to-day routines of diabetes patients.

Convenient for patients and doctors

Since the FreeStyle Libre Pro does not require any fingerstick calibrations, there is no need for diabetes patients to be trained on calibration. Once the sensor has been applied, there is no need for patients to interact with the system in any way.

Reduces equipment cost and time

Besides costing less than other CGM products, with the FreeStyle Libre Pro system the physician only needs to buy one specific reader for several patients without the need to spend on extra transmitters, receivers and recorders, or devoting time to disinfect or recharge other components.

Ambulatory Glucose Profile report

The system provides physicians and their patients with an AGP (Ambulatory Glucose Profile) report. The report was developed by the International Diabetes center and it is represented in a user-friendly chart that provides physicians with a complete glycemic view of the patient’s blood glucose trend for the past 14 days.

The Ambulatory Glucose Profile Report helps identify when patients are out of the ideal blood glucose range and provides hyperglycemic and hypoglycemic patterns and trends. These useful insights facilitate meaningful discussions between patients and doctors. This is groundbreaking technology primarily because professional CGM systems have been long considered an expensive and cumbersome technology particularly for Type 1 diabetes patients.

The new FreeStyle Libre Pro technology is here to change this paradigm because it’s not only unique but also because it does not require fingerstick calibration, it’s more affordable, easier to use and more accessible to diabetes patients.

Abbot has also submitted the FreeStyle Libre Pro system consumer version for review by the FDA. The consumer version of the system is a CGM system that measures blood glucose levels through a very small sensor on the back of the patient’s upper arm for 14 days. Moreover, it does not require fingerstick calibration and patients can self-monitor their blood glucose levels by simply scanning the reader over the small sensor to get a reading as often as desired.